Kornimate/medical-research-clean huggingface dataset:
mechanisms of benefit of il4ra inhibition in aspirin-exacerbated respiratory disease

Conditions: Nasal Polyps; Asthma, Aspirin-Induced; Aspirin-Exacerbated Respiratory Disease; Aspirin-Sensitive Asthma With Nasal Polyps

Summary: the overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-il-4a (dupilumab) as treatment for patients with aspirin-exacerbated respiratory disease (aerd).

the protocol involves an 8-week trial of dupilumab in patients with aerd. participants will have 4 total doses of dupilumab administered, with each dose administered every 2 weeks. there will be full clinical assessments and biospecimen collections at baseline (visit 1), week 2 (visit 2), and week 8 (visit 3).

Eligibility criteria:
key inclusion criteria: 1. history of aerd, defined as meeting the diagnostic triad with: 1. history of physician-diagnosed asthma and 2. history of physician-diagnosed nasal polyposis and 3. history of pathognomonic reactions to aspirin or other nonselective cox inhibitors. 2. visible nasal polyps bilaterally on otoscope physical exam at the time of screening. 3. evidence of sense of smell impairment, with a university of pennsylvania smell identification test (upsit) score of \<34. 4. stable asthma (no glucocorticoid burst for at least 4 weeks prior to visit 1, and no hospitalizations or er visits for asthma for at least the prior 3 months). 5. consistent (daily) use of an intranasal steroid for at least 4 weeks prior to screening. 6. no current smoking (not more than one instance of smoking in the last 3 months). 7. for females: practicing fda-approved methods of birth control for the duration of the study. female participants of childbearing potential must have a negative pregnancy test upon study entry. key exclusion criteria: 1. use of investigational drugs within 12 weeks of screening. 2. use of any biologic agent within 4 months prior to screening. 3. use of systemic (enteral or injected) glucocorticoids within 4 weeks prior to screening. 4. history of any sinonasal surgery within 4 months prior to screening 5. current use of zileuton 6. current use of high-dose aspirin therapy (no more than 325 mg aspirin per day will be allowed) 7. pregnant, nursing, or planning to become pregnant note: other inclusion and exclusion criteria apply.
neuroimaging guided and robot-assisted rtms for suicidal ideation of depression

Conditions: Suicidal Ideation; Depression

Summary: there is relatively insufficient evidence on whether rtms can improve suicidal ideation in depressive patients. and existing studies have been inconsistent in the treatment of depressive suicidal thoughts. the possible reason is inaccurate stimuli localization. improving the accuracy of rtms stimulus positioning may further improve the intervention effect of suicidal ideation. this study will introduce an automated tms system with robot control and optical sensor combined with neuronavigation softwarea. by using the robot based on neuronavigation system, the rtms coil can be accurately positioned over any preselected brain region. an infrared optical measurement device is also used in order to detect and compensate for head movements of the patient. the purpose of this randomized double-blind and sham-controlled study is to test the efficacy and safety of robot-assisted rtms based on neuronavigation in the treatment of depressive suicidal ideation.


Eligibility criteria:
inclusion criteria: * 18-60 years * meeting the criteria of the diagnostic and statistical manual of mental disorder- v of mdd, single or recurrent * have a score \> 17 on the hamd-17 * have a score ≥ 6 on the bsi-cv * right- handedness * physical examination, medical history, vital signs, blood routine, liver and kidney function, ecg, eeg and other indicators are normal * are voluntary and competent to consent to treatment exclusion criteria: * people with a history of severe physical illness and depression caused by psychoactive substances and non-dependent substances * patients with metal or electronic equipment, such as intracranial metal foreign bodies, cochlear implants, pacemakers and brace, etc. * risk of seizures, previous central nervous system diseases, head trauma, alcoholism, abnormal eeg, mri evidence of abnormal brain structure, or family history of epilepsy * acute suicide * have psychotic symptoms and need to use antipsychotic drugs * receive ect treatment within 2 months * pregnant, breastfeeding or planning to become pregnant during the trial * refuses to sign the consent

Keywords: suicidal ideation depression neuronavigation robot-assisted rtms rtms
open-label prospective clinical trial evaluating the safety and efficacy of biosynthetic clp-peg-mpc corneal implants in patients undergoing high-risk deep anterior lamellar keratoplasty.

Conditions: High-risk Corneal Transplantation; Corneal Blindess; Corneal Inflammation; Deep Anterior Lamellar Keratoplasty

Summary: this is an open-label and prospective clinical trial, in which a maximum of 5 eyes of 5 patients will receive a clp-peg-mpc synthetic cornea during deep anterior lamellar keratoplasty (dalk) surgery and will be followed up over 24 months.

this is a prospective open-label clinical trial of patients who will receive a clp-peg-mpc synthetic cornea during deep anterior lamellar keratoplasty (dalk) corneal transplantation surgery and be followed over 24 months. the primary objective is to demonstrate the safety and tolerability of clp-peg-mpc biosynthetic corneal implants. the secondary objective is to examine the preliminary efficacy of these implants to stimulate corneal tissue regeneration, provide optical clarity and improvement of vision. randomization is not appropriate in a first-in-human pilot study. blinding is not possible as surgeons can easily tell a cell-free implant apart from a donor allograft.

Eligibility criteria:
inclusion criteria: 1. adult age (18 years or older at the time of subject eligibility visit) 2. able to provide signed, informed consent 3. unilateral corneal opacity not involving the posterior corneal layers (descemet membrane and endothelium) for which dalk is indicated 4. visual acuity less than 20/200 in the affected eye and better than 20/50 in the contralateral eye (i.e. monocular blindness) 5. presence of at least one of the following high-risk criteria for corneal transplantation using a human cornea donor graft: 5i) inflammation 5ii) active infection 5iii) stromal neovascularization 5iv) neurotrophism 5v) autoimmune disease 5vi) previous dalk graft failure 6. availability for 24 months of postoperative follow-up exclusion criteria: 1. age under 18 years 2. inability to give informed consent 3. previous corneal perforation precluding dalk surgery 4. endothelial pathology requiring penetrating keratoplasty 5. limbal stem cell deficiency affection more than 50% of the limbus 6. previous penetrating or endothelial keratoplasty 7. bilateral blindness 8. nystagmus 9. uncontrolled glaucoma or intraocular pressure 10. documented macular disease (age-relate macular degeneration, macula-involving retinal detachment, macular hole) 11. documented amblyopia of surgical eye

Keywords: cornea biosynthetic implants tissue regeneration
telehealth following orthopaedic procedures

Conditions: Post-Op Complication

Summary: this study aims to evaluate the quality of care provided by a home-based teleheath program as a safe and acceptable alternative to an in-person office visit as determined by satisfaction with the program and the amount of further medical management required by the patients.


Eligibility criteria:
inclusion criteria: 1. subjects over 18 and under 75 years of age undergoing elective primary orthopaedic surgery at thomas jefferson university hospital, rothman orthopaedic specialty hospital or methodist hospital who have the capability to utilize a telecommunications platform (computer, tablet or similar device at home with a webcam, microphone and access to high-speed internet). exclusion criteria: 1. subjects who are unable to access the telemedicine platform or who are uncomfortable with following up in this fashion 2. subjects who are unable or unwilling to provide post-operative radiographs electronically or who are unable or unwilling to obtain them 3. subjects with workman's compensation or automotive claims or other ongoing litigation 4. subjects that are unable or unwilling to consent for enrollment 5. patients under the age of 18 years 6. pregnant or breastfeeding women 7. patients undergoing surgery for tumor, trauma or infection or who require revision or staged procedures 8. patients without english-language proficiency 9. patients with unforeseen intra-operative or perioperative complications
use of public health surveillance models in the french national health system database

Conditions: Atrial Fibrillation; Anticoagulants; Pharmacoepidemiology

Summary: public health surveillance models, previously used for the ongoing detection of occurrence of rare events, could be used to reinforce existing pharmacovigilance systems. these models have not been previously used for adverse drug reaction (adr) detection in medico-administrative databases. dabisurv research project focuses on a new anticoagulant therapy, dabigatran, launched recently on the french market for atrial fibrillation (af). this drug is at high risk for severe adr and requires thus careful pharmacovigilance monitoring. primary objective is to compare the results of ongoing surveillance models to detect hemorrhages or acute myocardial infarction (ami) associated with dabigatran, with the results obtained from the analysis of a cohort of patients with af under the same treatment.

dabisurv study consists in an analyze of a cohort of patients with af who have received at least one prescription vitamin k antagonists (vka) - reference group - or of dabigatran in the french national health insurance system. the uptake of dabigatran is followed for detecting hemorrhagic events or ami associated with this molecule among first users. the ability to detect quickly substantial adr of new drugs is of critical importance to public health in order to facilitate timely public health response. if the public health surveillance models are found useful for this topic, then semi-automated procedures would be needed to detect adr associated with new generation anticoagulants in medico-administrative databases. if the public health surveillance models are found not useful for the detection of adr, the cohort study itself will provide essential data on the safety profile of dabigatran.

Eligibility criteria:
inclusion criteria: * patients with non-valvular atrial fibrillation * patients receiving an first prescription of anticoagulants exclusion criteria: * patients with valvular atrial fibrillation

Keywords: atrial fibrillation anticoagulants pharmacoepidemiology
effects of phenylephrine on cardiac preload

Conditions: Arterial Hypotension; Anaesthesia

Summary: in patients under general anesthesia, episodes of hypotension are often treated with phenylephrine. the effect of phenylephrine is conventionally attributed to afterload increase. the aim of the study is to describe the time course of the effects of phenylephrine on the cardiac preload and cardiac output, and to evaluate whether phenylephrine, as an exclusive alpha-mimetic, could be beneficial for preload optimisation.

in consecutive patients scheduled for laparoscopic sigmoidectomy, all hemodynamic and respiratory variables are recorded electronically for subsequent offline analysis. all patients are ventilated in volume control mode with a tidal volume of 8 ml/kg ideal body weight. during steady-state target controlled infusion (tci) propofol/remifentanil anesthesia, when the mean arterial blood pressure (map) dropped below 80% of the awake state for at least 5 minutes, a phenylephrine bolus of 2 μg/kg is administered. if necessary this is repeated, or a continuous administration of phenylephrine is started at a rate of 10-30 μg/kg/u. all patient manipulations during the procedure are electronically recorded and time stamped for subsequent off-line data analysis. the first episode in each patient where phenylephrine is administered and in a period of at least 10 minutes when minimal or absent patient manipulation occurred, the hemodynamic variables are analysed to describe the effects of phenylephrine administration on the dynamic preload parameters and macro-hemodynamics.

Eligibility criteria:
inclusion criteria: * adult * necessity for arterial blood pressure monitoring * necessity for central venous blood pressure monitoring exclusion criteria: * unwilling or unable to grant written informed consent * cardiac arrythmia * contra-indication for phenylephrine * contra-indications for atropine * contra-indication for total intravenous anesthesia

Keywords: phenylephrine alpha mimetics pulse pressure variation venous return
safety, tolerability, pharmacokinetics, and pharmacodynamics of incb099280 in participants with advanced solid tumors

Conditions: Advanced Solid Tumor; MSI-H/dMMR Tumors; Cutaneous Squamous Cell Carcinoma; Urothelial Carcinoma; Cervical Cancer; HepatoCellular Carcinoma; Esophageal Squamous Cell Carcinoma; Merkel Cell Carcinoma; Small-cell Lung Cancer; Mesothelioma; PD-L1 Amplified Tumor (9p24.1); Nasopharyngeal Carcinoma

Summary: the purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of incb099280 in participants with select solid tumors


Eligibility criteria:
inclusion criteria: * must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment. * histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per response evaluation criteria in solid tumors version 1.1 (recist v1.1) that are considered nonamenable to surgery or other curative treatments or procedures. * eastern cooperative oncology group performance status score of 0 or 1. * life expectancy \> 12 weeks. * willingness to avoid pregnancy or fathering children. exclusion criteria: * laboratory values outside the protocol-defined ranges. * clinically significant cardiac disease. * history or presence of an electrocardiogram that, in the investigator's opinion, is clinically meaningful. * untreated brain or central nervous system (cns) metastases or brain or cns metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or cns metastases). * known additional malignancy that is progressing or requires active treatment. * has not recovered to ≤ grade 1 or baseline from toxic effects of prior therapy (including prior io) and/or complications from prior surgical intervention before starting study treatment. * prior receipt of an anti-pd-l1 therapy. * treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. * a 28-day washout for systemic antibiotics is required. * probiotic usage while on study and during screening is prohibited. * active infection requiring systemic therapy. * known history of human immunodeficiency virus (hiv) * evidence of hepatitis b virus or hepatitis c virus infection or risk of reactivation.

Keywords: advanced solid tumor
advanced neuroimaging in idiopathic intracranial hypertension

Conditions: Idiopathic Intracranial Hypertension (IIH); Glymphatic System

Summary: idiopathic intracranial hypertension (iih) is characterized by elevated intracranial pressure leading to symptoms like papilledema, headache, and cognitive dysfunction. while the etiology is complex, abnormal cerebrospinal fluid dynamics due to venous outflow restriction from transverse sinus stenosis (tss) is common. tss may disrupt the glymphatic system, a brain-wide network facilitating cerebrospinal fluid and interstitial fluid exchange, by impairing csf absorption, altering perivascular space dynamics, and disrupting pressure gradients crucial for waste clearance. venous sinus stenting (vss) can improve symptoms in many patients by alleviating venous congestion, but its effects on glymphatic function are unclear. this prospective study aims to evaluate novel quantitative brain imaging metrics as surrogate markers to better understand iih pathophysiology before and after vss in patients with refractory iih and tss. the investigators will use advanced mri techniques, including mr elastography (mre) to assess brain stiffness, diffusion tensor imaging (dti) to evaluate water diffusion, arterial spin labeling (asl) imaging to measure blood-brain barrier (bbb) permeability, and functional mri to analyze pain networks. the investigators hypothesize that 1) these noninvasive imaging metrics will correlate with the degree of venous congestion and changes after venous sinus stenting (vss) and 2) the imaging findings will correlate with clinical treatment outcomes. by correlating imaging markers with venous pressures and symptom changes, the investigators aim to gain insights into iih mechanisms, expand diagnostic tools, and potentially guide clinical decision-making and treatment response monitoring. the overarching goal is to better understand iih's underlying pathophysiology, which could lead to improved diagnostic criteria, more targeted treatments, and better prediction of treatment outcomes for patients with this challenging condition.


Eligibility criteria:
inclusion criteria: • refractory iih patients who require and plan to have a venous sinus stenting exclusion criteria: * history of head trauma and shunting or leak repair * major concurrent, active non-cephalic pain syndrome * contradictions for mris

Keywords: idiopathic intracranial hypertension mri diffusion tensor imaging iih
comparison of manual therapy versus radial shock waves in the shoulder pain treatment

Conditions: Shoulder Impingement; Shoulder Pain

Summary: subacromial syndrome represents the third leading cause of pain in the general population. there is no clear pathophysiological explanation, nor a specific treatment. manual therapy stands out as one of the reference treatments for this disease, however, it is complex to develop a specific protocol. on the other hand, shock waves have still not received adequate attention in the treatment of this pathology. the aim of this study will focus on using manual treatment using ischemic pressure, joint mobilizations and myofascial techniques in comparison to shock wave therapy to determine which is more effective. this study will be a randomized, single-blind clinical trial with third-party evaluation. in it 88 subjects suffering from subacromial syndrome will participate. 44 patients will receive treatment through manual therapy over 6 weeks and other 44 patients through low-med energy radial shock waves for 6 weeks. all subjects will complete their treatment with a 12-week home-based therapeutic exercise program. the main endpoint of the study will be pain measured using the visual analogue scale (vas) in motion. pain will also be assessed using the vas scale at rest and overnight. the spadi spanish version questionnaire will be used, shoulder strength will be measured using a handheld dynamometer and the ranges of motion will be measured. data will be measured before and one year after treatment.


Eligibility criteria:
inclusion criteria: * unilateral shoulder pain with no history of trauma. * pain of at least 4/10 on the visual analogue scale for a minimum period of 3 months. * be positive in at least 3 of the following 5 tests: painful arc test, neer impingement test, hawkins-kennedy test, jobe test, external rotation test against resistance for the infraspinatus tendon. exclusion criteria: * presence of red flags. * diagnosis of shoulder instability. * diagnosis of frozen shoulder. * diagnosis of complete rupture of the common rotator cuff tendon. * diagnosis of cervical radiculopathy. * diagnosis of whiplash. * diagnosis of degenerative disease of the glenohumeral joint.
microfracture technique for talar articular cartilage lesions with or without lateral ligament repairment

Conditions: Lateral Ligament Repair; Talar Cartilage Lesion; Microfracture

Summary: to study the clinical efficacy of microfracture combined with lateral ligament repairment for cartilage lesions of talus through the comparison between microfracture with and without lateral ligament repairment.


Eligibility criteria:
inclusion criteria: full - thickness cartilage injury exclusion criteria: age: \> 40 years old or \ 30; lesion \> 4 cm2
effects of two doses of mpx capsules on rising prostate-specific antigen levels in men following initial therapy for prostate cancer

Conditions: Prostate Cancer

Summary: this research is being done to test an investigational product called muscadine plus in the treatment of men who have received initial therapy (surgery and or radiation, cryotherapy or brachytherapy) for prostate cancer and are experiencing a rise in their prostate-specific antigens (psa) level.

in phase i the investigators are evaluating the safety of the product and checking blood levels of the active components. in phase ii the investigators are evaluating the effect of mpx on psa doubling time

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate. * undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor. * rising psa on a minimum of 3 time points (including screening psa) within the 12 months prior to study initiation. * \> 18 years of age. * life expectancy of greater than 6 months. * eastern cooperative oncology group (ecog) performance status 0, 1 or 2. * testosterone level of ≥1.5 ng/ml at screening. * adequate kidney, liver and bone marrow function * agrees to abstain from other commercially available mp products while participating in this study. * subject's use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc) has been stable for at least 2 months prior to screening and the subject agrees not to stop or change the dose(s) while participating in the study. * signed a written informed consent document and agrees to comply with requirements of the study. exclusion criteria: * known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology. pelvic/intraperitoneal lymph nodes less than 2.0 cm maybe considered nonspecific and the patient would be eligible * receipt of any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, 5 alpha reductase inhibitors) for a minimum of 6 months prior to study * prior or concomitant treatment with experimental drugs, high dose steroids, or any other cancer treatment within 4 weeks prior to the first dose of the study product * consumption of muscadine plus over the past 2 months * known allergy to muscadine grapes or ellagic acid * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * negative psa doubling time (1 time point may be excluded per 3e inclusion criteria)

Keywords: rising psa